NCT02756403

Brief Summary

This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures. In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three commonly used antibiotics (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior to their abortion procedure. Approximately, 30-60 mins after study drug administration, the procedure will be performed. A sub-study will be completed on 40 women who consent to endometrial sampling and to have their blood drawn.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

February 11, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

March 20, 2016

Results QC Date

December 8, 2020

Last Update Submit

February 10, 2022

Conditions

First Trimester Abortion

Outcome Measures

Primary Outcomes (2)

  • Nausea Scale

    Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)

    1 Day

  • Emesis Severity

    Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)

    1 Day

Secondary Outcomes (3)

  • Pain Scale

    Day 1

  • Serum Antibiotic Levels

    3 hours

  • Endometrial Growth

    3 Days

Study Arms (4)

Azithromycin

ACTIVE COMPARATOR

500 mg of Azithromycin

Drug: Azithromycin

Doxycycline

ACTIVE COMPARATOR

200 mg of Doxycycline

Drug: Doxycycline

Metronidazole

ACTIVE COMPARATOR

500 mg of Metronidazole

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Inactive Ingredient

Drug: Placebo

Interventions

AzithromycinDRUG

500 mg

Azithromycin
DoxycyclineDRUG

200 mg

Doxycycline
MetronidazoleDRUG

500 mg

Metronidazole
PlaceboDRUG

Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women in good general health.
  • English speaking.
  • Age 18 or over.
  • Seeking non-urgent surgical termination of pregnancy.
  • Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.

You may not qualify if:

  • Less than 18 years of age.
  • Early pregnancy failure or fetal demise.
  • Poor general health that would prevent one from tolerating the medication or surgical procedure.
  • Intolerance, allergy, or contraindication to any of the study medications.
  • Inability to tolerate oral intake due to current nausea or vomiting.
  • Diagnosis of hyperemesis gravidarum with current pregnancy.
  • Need of an urgent surgical abortion.
  • Gestational age outside of 5-13 6/7 weeks by sonogram.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Planned Parenthood Metropolitan Washington

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Interventions

AzithromycinDoxycyclineMetronidazole

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Principal Investigator
Organization
MedStar Washington Hospital Center
peggy.ye@medstar.net
202-877-7479

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2016

First Posted

April 29, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 11, 2022

Results First Posted

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)